My client is a global Biotechnology company specializing in the on-going development and commercialization of products targeting cancer, critical care and other disorders. Due to continued growth, we have an exciting opportunity for a Process Engineer to join out highly motivated team.
The Process Engineer will be working within manufacturing as part of the Manufacturing Technical Support function; provide technical expertise and process knowledge to the manufacturing and supply functions and deliver improvement projects, process validation and new product introductions, to increase the efficiency, effectiveness and success of Manufacturing and Supply Operations.
Acting as subject matter expert to support delivery of medium to long term projects; to ensure availability of capacity and capability to meet commercial demand.
Use technical expertise and influence to identify opportunities for process improvement projects for medical device and drug device combination products. Complete implementation through generation of data/technical justification, implementation and qualification.
Provide expert technical/process knowledge and investigation expertise for significant quality events in all areas of the manufacturing process. Lead identification of root cause and implementation of effective CAPAs; ensuring delivery is completed in a compliant matter.
Implementation of change controls for process or equipment changes within Manufacturing.
Lead and manage the process of technical transfers (including process development, scale up and new product introduction) from development to manufacturing and between sites/companies. Ensure that actions are tracked for compliance and delivery in line with agreed plans and provide regular updates/feedback to key stakeholders to ensure visibility of project progress is maintained.
Support validation activities for commercial manufacturing to ensure that processes are maintained in a validated and compliant state.
Education and Experience
Educated to degree level in Mechanical/Chemical/Process Engineering, or with significant medical device and/or pharmaceutical industry experience supported by alternative qualifications.
Experience of Manufacturing or Product Development in the Pharmaceutical and/or Medical Device industry (other highly regulated and quality driven industries may be considered).
Lean Six Sigma Green Belt Accredited
Knowledge of cGMP, ISO13485, 21CFR 820 and other relevant regulatory requirements.
Project management experience/qualification (e.g. Prince2) would be advantageous.
Demonstrated experience in delivering new equipment/processes into manufacturing, through sourcing, development, qualification to commercialisation.
Demonstrated experience in existing process and equipment optimisation and validation.
Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.
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